On May 9, 2025, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) announced a groundbreaking joint research initiative, the Nutrition Regulatory Science Program. This collaborative effort is a key element in fulfilling U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr.'s commitment to Make America Healthy Again.

The Urgent Need for Action

With diet-related chronic diseases on the rise, it is imperative that the FDA and NIH work together to invest in gold standard science and prioritize a better understanding of the root causes of these diseases. The Nutrition Regulatory Science Program aims to address this crisis by providing critical information to inform effective food and nutrition policy actions, ultimately making Americans' food and diets healthier.

Research Agenda

The program will focus on answering crucial questions, including:

• How and why can ultra-processed foods harm people's health?
• How might certain food additives affect metabolic health and possibly contribute to chronic disease?
• What is the role of maternal and infant dietary exposures on health outcomes across the lifespan, including autoimmune diseases?

By answering these questions and many others, the program will enable effective policy development and promote radical transparency about the foods Americans eat and how they impact their health.

A Powerful Partnership

The FDA will provide its critical expertise in regulatory science, while NIH will provide the infrastructure for the solicitation, review, and management of scientific research. This collaboration will bring together experts from various disciplines, including chronic disease, nutrition, toxicology, risk analysis, behavioral science, and chemistry, to advance the gold standard of nutrition and food science.

A Shared Commitment to Progress

"The FDA is focusing resources on the greatest contributors to the staggering health care crisis: chronic diseases," said FDA Commissioner Martin A. Makary, M.D., M.P.H. "Mirroring the highly successful FDA and NIH Tobacco Regulatory Science Program, we're bringing together scientific expertise from both agencies to transform nutrition and food-related research."

"Nutrition has always been a priority at NIH. By teaming up with the FDA, we're taking a major step toward answering big questions about how food affects health—and turning that science into smarter, more effective policy. It's time to tackle the chronic disease crisis head-on. That's why NIH is making this investment alongside the FDA," said NIH Director Jay Bhattacharya, M.D., Ph.D.

Ensuring Integrity and Independence

The FDA and NIH are committed to ensuring that all research conducted under the Nutrition Regulatory Science Program is fair, independent, and free of conflicts of interest.

References

• FDA Website (May 9, 2025) - FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program